SYDNEY - The stock price of influenza-cure company Biota Australia Ltd. surged last week after its development partner, Glaxo Wellcome plc, revealed test results showing the drug Relenza had a distinct advantage in preventing as well as curing flu.
Biota's share price increased A$0.20 to A$5.36 (US$3.14) last Thursday, with the stock finishing the week at A$5.40, after the announcement of encouraging results from Phase III tests of Relenza as a flu cure, as well as additional tests of the drug's ability to prevent flu.
In addition, the company told the Australian Stock Exchange that London-based Glaxo had applied to the regulatory authorities in Europe and Canada for approval to market the drug for prevention as well as treatment.
However, the all-important U.S. filing has not occurred, so the drug will not reach the U.S. market in time for the start of the Northern Hemisphere's flu season, which is now only a few weeks away.
Sydney-based Biota's chief financial officer, Richard Wadley, said the results of two separate Phase III trials for Relenza were presented at the 38th Interscience Conference on Antimicrobal Agents and Chemotherapy in San Diego over the weekend.
The first trial involved about 1,000 healthy college students given Relenza and then checked to see how many developed the flu. Wadley said the trial showed Relenza was effective in preventing the test subjects from getting the flu.
The second Phase III study, involving about 3,000 people, examined the drug's effectiveness in curing flu. Again, the results were sufficiently encouraging for Glaxo to proceed with European and Canadian applications for registration, he said.
Biota's announcement to the stock exchange states that in the Phase III trial testing Relenza's ability to cure flu, patients with influenza were given a dose of 10 mg twice daily for five days. The drug was administered through an inhaler.
The patients had noticeably less-severe symptoms throughout the course of their illness, and attained relief from the major symptoms of the disease up to two and a half days earlier than those receiving a placebo.
In addition, the results showed a reduction in flu-associated complications in high-risk patients, including the elderly and those with respiratory and cardiovascular disease. The statement also noted that the majority of patients given Relenza for prevention of influenza, in doses of 10 mg once daily for four weeks, were protected from acquiring the flu. There were no noticeable side effects from the drug.
Relenza was developed in Australia in the 1980s and was licensed to Glaxo by Biota in 1989. It is a neuraminidase inhibitor, which works by blocking the enzyme neuraminidase, present on the surface of the virus. Unlike the rest of the virus, that enzyme does not change for each different strain of the virus.
In addition to Relenza, Biota has a number of research projects in its portfolio, including an insulin tablet. *